NDC 0597-7705-38 - SPEVIGO
This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.
- Product NDC
- 0597-7705
- Requested NDC
- 0597-7705-38
- Package NDCs from labels
- 0597-7705-38, 0597-7705-72, 0597-7705-41
- Manufacturer
- Boehringer Ingelheim Pharmaceuticals, Inc. | Boehringer Ingelheim Pharma GmbH and Co. KG | West-Ward Columbus Inc.
- Effective date
- 2026-04-08
- Current FDA listing
- Not matched in FDA.report NDC product tables
DailyMed Labels#
| Label | Manufacturer | Effective date | Type |
|---|---|---|---|
| SPEVIGO | Boehringer Ingelheim Pharmaceuticals, Inc. | Boehringer Ingelheim Pharma GmbH and Co. KG | West-Ward Columbus Inc. | 2026-04-08 | HUMAN PRESCRIPTION DRUG LABEL |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0597-7705-38 | SPEVIGO | 300 mL in 1 SYRINGE | INJECTION | 300 | 6 | |
| 0597-7705-41 | SPEVIGO | 1 in 1 CARTON | INJECTION | 1 | 6 | |
| 0597-7705-72 | SPEVIGO | 2 in 1 CARTON | INJECTION | 2 | 6 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0597-7705-38 | ML - Milliliter | 0597-7705 | 2f22c50e-ae7a-4fb4-89bf-052abef2084d | 1 | 2026-05-22 |
| 0597-7705-41 | ML - Milliliter | 0597-7705 | 3bb7d54d-cb66-4901-ad94-6fa3fbbc19a2 | 1 | 2025-08-11 |
| 0597-7705-72 | ML - Milliliter | 0597-7705 | f6502c01-e558-4947-99ea-b1258192e8e8 | 1 | 2025-08-11 |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| SPEVIGO | SPESOLIMAB-SBZO | Boehringer Ingelheim Pharmaceuticals, Inc. | 41a481ee-3062-45d1-aed5-17e8b105634d | 2026-04-08 | Warnings, Adverse reactions | BLA761244 0597-0620-20 0597-0620-10 0597-0035-10 0597-7705-72 0597-7705-38 0597-7705-41 0597-7705 0597-0620 0597-0035 00597770538 2610428 2610422 2716697 2678984 2716696 2678979 021b29b5-64ea-411e-91a8-c1f5015c3d9c 41a481ee-3062-45d1-aed5-17e8b105634d 5IB2J79MCX |
| SPEVIGO | SPESOLIMAB | LEO Pharma Inc. | 78a4f7eb-8d34-4467-8d40-74ed24323806 | 2026-03-16 | Warnings, Adverse reactions | BLA761244 2610428 2610422 2716697 2678984 2716696 2678979 5IB2J79MCX |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.